Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
NCT ID:
NCT01231503
Description:
Unsolicited AEs: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group. Please note that safety analysis for solicited symptoms and unsolicited AEs was performed only on subjects with available results.
Frequency Threshold:
5
Time Frame:
Solicited symptoms: Within 7 days (Days 0-6) after vaccination at Weeks 0, 6, 10, 14, 26 and Month 9; SAES: During the entire study period, from Month 0 to Month 18 (corresponding data lock point date = 23 March 2015)
Study:
NCT01231503
Study Brief:
Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| RTS,S Neo-10-14 Group | Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 0 | None | 7 | 60 | 36 | 60 | View |
| RTS,S 6-10-14 Group | Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 0 | None | 6 | 60 | 28 | 58 | View |
| Engerix-B Neo/RTS,S 6-10-26 Group | Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 0 | None | 8 | 60 | 35 | 60 | View |
| RTS,S 10-14-26 Group | Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 1 | None | 12 | 60 | 36 | 59 | View |
| RTS,S Neo-10-26 Group | Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 0 | None | 5 | 59 | 35 | 59 | View |
| RTS,S 6-10-26 Group | Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 0 | None | 9 | 60 | 29 | 60 | View |
| RTS,S 14-26-9M Group | Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 0 | None | 5 | 60 | 47 | 60 | View |
| Engerix-B Neo Group | Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 0 | None | 4 | 60 | 31 | 59 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Bronchiolitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Gastroenteritis rotavirus | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Jaundice neonatal | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA | View |
| Malaria | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Respiratory distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Sepsis neonatal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Acute respiratory distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Cerebral malaria | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Drowning | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA | View |
| Escherichia sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA | View |
| Malnutrition | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA | View |
| Meningitis neonatal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Meningitis pneumococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pneumococcal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Malaria | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Redness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Irritability | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |
| Fever (axillary temperature >= 37.5°C) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA | View |